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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03905187
Other study ID # 301CRS20181228
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 16, 2019
Est. completion date September 1, 2021

Study information

Verified date April 2019
Source Chinese PLA General Hospital
Contact Jing Ma
Phone +8613681257396
Email crystalma@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.


Description:

The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1200
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure

Exclusion Criteria:

- Uncontrolled tachycardia (heart rate at rest >120bpm

- Uncontrolled polypnea(breath rate at rest >30 breath per minute

- Uncontrolled respiratory failure (SPO2 =90%)

- Uncontrolled hypertension (pre-exercise SBP>180mmHg or DBP>110mmHg)

- Weight change in 72 hours >1.8kg

- Uncontrolled hyperglycemia (Random blood glucose>18mmol/L)

- Uncontrolled malignant arrhythmia with hemodynamic instability

- Unoperated pseudoaneurysm?artery dissection

- Uncontrolled septic shock and septicopyemia

- Unoperated severe valvular heart disease or acute phase of heart failure caused by myocardial heart disease

- nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise

- Uncooperation of the patients

Study Design


Intervention

Behavioral:
Modified CR
Stress management involved modified cardiac rehabilitation
Traditional CR
Traditional cardiac rehabilitation
Education
Education

Locations

Country Name City State
China Chinese PLA General Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Jing Ma

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The score of anxiety test questionnaire decreased The score of anxiety test questionnaire(Generalized Anxiety Disorder,GAD-7, normal range 0-21, partially reflecting the severity of anxiety with the higher score) decreased 6 month
Primary The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (abbreviation form is 36-Item Short Form Survey) increased. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, The sections consists of Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health. The total score of SF 36 Health survey is higher, the quality of life is higher. 6 month
Primary The score of patient health questionnaire decreased The score of patient health questionnaire (PHQ9, normal range 0-27,indicating the profile of depression with the higher score) decreased 6 month
Primary The score of Chinese perceived stress scale decreased. The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased. 6 month
Secondary incidence of MACE in patients after acute myocardial infarction any incidence of the following: death, cardiac death, AMI, revascularization, stroke 6 month
Secondary incidence of MACE in patients with heart failure death, cardiac death, resynchronization 6 month
Secondary improvement of exercise capacity 6 minute walking distance 6 month
Secondary incidence of rehospitalization incidence of rehospitalization 6 month
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